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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameVARIOUS PAVEMAKERS, CARELINK MONITOR, CARDIOSIGHT READER
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP890003
Supplement NumberS115
Date Received12/20/2006
Decision Date01/30/2007
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic models 2490g (rev. T application software version 5v3); medtronic 2020a cardiosight reader (application software version 5v3); and medtronic 2491 ddma software. The medtronic 2491 ddma software contains the xml translation utility (xmltu) software version v17, the presenting waveform utility (pwf) software version 16v1, and the session data decode (sdd) software version 1v2.
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